HeartSine AED Recall: Membrane Tail Fault Can Disable Life-Saving Shocks

Health Canada has issued a Type II medical device recall for HeartSine® Samaritan® PAD automated external defibrillators after manufacturer Stryker identified an internal component fault that can render the devices inoperable during a cardiac emergency. The affected models include the SAM 350P, SAM 360P, and SAM 500P defibrillators, which are used to deliver life-saving electric shocks to patients experiencing sudden cardiac arrest.

What Products Are Being Recalled?

The recall covers multiple HeartSine samaritan PAD units across the 350P, 360P, and 500P model lines, distributed under model or catalogue numbers including 500-STR-CN-10, 500-BAS-CN-10, 360-BAS-CN-10, 360-BAS-CF-10, 360-STR-CN-10, 360-TSO-CN-10, 350-TSO-CN-10, 350-BAS-CN-10, 350-BAS-CF-10, and 350-STR-CN-10. According to Health Canada, the affected lot or serial numbers span ‘more than 10 numbers’ and owners are advised to contact the manufacturer directly to confirm whether their specific unit is impacted. The devices are manufactured by Heartsine Technologies, Ltd., based in Belfast, Northern Ireland, and are classified under Health Canada’s Cardiovascular medical device category.

Why Was This Recall Issued?

Stryker identified an issue with the ‘membrane tail,’ an internal component of the device, that can cause an intermittent fault. Health Canada states this failure could occur at any point when the device is holding a charge in preparation to deliver therapy, while delivering a shock, or after shock delivery has occurred. Once the fault occurs, the device becomes completely inoperable, meaning it may fail to deliver a potentially life-saving shock during a sudden cardiac arrest emergency, posing a serious risk to patient safety.

Who Is Affected?

This recall is directed at an industry audience, including hospitals, clinics, first responders, workplaces, and any organizations or individuals that own or maintain HeartSine samaritan PAD 350P, 360P, or 500P defibrillator units. Anyone responsible for maintaining these devices for emergency use should check their equipment against the affected model and catalogue numbers listed by Health Canada.

What Should You Do?

Health Canada advises that anyone requiring additional information should contact the manufacturer directly. Organizations and individuals who own an affected HeartSine samaritan PAD device should not assume their unit is safe for use in an emergency until they have confirmed its status with the manufacturer, since the recall involves more than 10 distinct lot or serial numbers. Facilities relying on these defibrillators for emergency preparedness should verify their equipment promptly and follow any additional guidance issued by Stryker or Heartsine Technologies to ensure continued readiness for cardiac emergencies.

Official Statement

Health Canada published this alert on July 22, 2026, describing it as a ‘health product recall’ affecting devices within the Cardiovascular category. The recall notice states plainly that ‘Stryker has recently identified an issue with the membrane tail, an internal component, which could cause an intermittent fault,’ and confirms the device becomes inoperable after such a failure occurs. The recall is designated Type II and carries identification number RA-82380.